To test the hypothesis that hypoglycemia unawareness is largely secondary to recurrent therapeutic hypoglycemia in IDDM, we assessed neuroendocrine and symptom responses and cognitive function in 8 patients with short-term IDDM (7 yr) and hypoglycemia unawareness. Patients were assessed during a stepped hypoglycemic clamp, before and after 2 wk and 3 mo of meticulous prevention of hypoglycemia, which resulted in a decreased frequency of hypoglycemia (0.49 +/- 0.05 to 0.045 +/- 0.03 episodes/patient-day) and an increase in HbA1c (5.8 +/- 0.3 to 6.9 +/- 0.2%) (P < 0.05). We also studied 12 nondiabetic volunteer subjects. At baseline, lower than normal symptom and neuroendocrine responses occurred at lower than normal plasma glucose, and cognitive function deteriorated only marginally during hypoglycemia. After 2 wk of hypoglycemia prevention, the magnitude of symptom and neuroendocrine responses (with the exception of glucagon and norepinephrine) nearly normalized, and cognitive function deteriorated at the same glycemic threshold and to the same extent as in nondiabetic volunteer subjects. At 3 mo, the glycemic thresholds of symptom and neuroendocrine responses normalized, and surprisingly, some of the responses of glucagon recovered. We concluded that hypoglycemia unawareness in IDDM is largely reversible and that intensive insulin therapy and a program of intensive education may substantially prevent hypoglycemia and at the same time maintain the glycemic targets of intensive insulin therapy, at least in patients with IDDM of short duration.
Aims/hypothesis: The largely unsatisfactory results reported for the pharmacological treatment of diabetic neuropathy has spurred the search for alternative therapies. The aim of this study was to evaluate the efficacy of frequency-modulated electromagnetic neural stimulation (FREMS) as a novel treatment for painful diabetic neuropathy. Methods: Patients (n=31) with painful neuropathy associated with decreased nerve conduction velocity (<40 m/s) and increased vibration perception threshold (>25 V) were enrolled in a randomised, double-blind, crossover study designed to compare the effects of FREMS with those of placebo. Each patient received two series of ten treatments of either FREMS or placebo in random sequence, with each series lasting no more than 3 weeks. The primary efficacy end point was the change in pain measured by a visual analogue scale (VAS). Results: FREMS induced a significant reduction in daytime and night-time VAS pain score (all p<0.02). Furthermore, FREMS induced a significant increase in sensory tactile perception, as assessed by monofilament; a decrease in foot vibration perception threshold, as measured by a biothesiometer; and an increase in motor nerve conduction velocity (all p<0.01). No significant changes were observed after placebo. Comparison of measurements at the 4-month follow-up with those at baseline revealed that a significant benefit persisted for all measures that showed an improvement at the end of treatment, with an additional improvement in quality of life evaluated by the Short Form-36 questionnaire (all p< 0.05). No significant side effects were recorded during the study. Conclusions/interpretation: FREMS is a safe and effective therapy for neuropathic pain in patients with diabetes and is able to modify some parameters of peripheral nerve function.
The simpler glargine regimen decreases the percentage of HbA(1c) and frequency of hypoglycaemia and improves responses to hypoglycaemia more than NPH. Thus, glargine appears more suitable than NPH as basal insulin for intensive treatment of T1 DM.
OBJECTIVE -To establish differences in blood glucose between different regimens of optimized basal insulin substitution in type 1 diabetic patients given lispro insulin at meals, i.e., NPH injected four times a day versus glargine insulin once daily at dinner or at bedtime. RESEARCH DESIGN AND METHODS-A total of 51 patients with type 1 diabetes on intensive therapy (NPH four times/day and lispro insulin at each meal) were randomized to three different regimens of basal insulin substitution while continuing lispro insulin at meals: continuation of NPH four times/day (n ϭ 17), once daily glargine at dinnertime (n ϭ 17), and once daily glargine at bedtime (n ϭ 17) for 3 months. Blood glucose targets were fasting, preprandial, and bedtime concentrations at 6.4 -7.2 mmol/l and 2 h after meals at 8.0 -9.2 mmol/l. The primary end point was HbA 1c .RESULTS -Mean daily blood glucose was lower with dinnertime glargine (7.5 Ϯ 0.2 mmol/l) or bedtime glargine (7.4 Ϯ 0.2 mmol/l) versus NPH (8.3 Ϯ 0.2 mmol/l) (P Ͻ 0.05). A greater percentage of blood glucose values were at the target value with glargine at dinner and bedtime versus those with NPH (P Ͻ 0.05). HbA 1c at 3 months did not change with NPH but decreased with glargine at dinnertime (from 6.8 Ϯ 0.2 to 6.4 Ϯ 0.1%) and glargine at bedtime (from 7.0 Ϯ 0.2 to 6.6 Ϯ 0.1%) (P Ͻ 0.04 vs. NPH). Total daily insulin doses were similar with the three treatments, but with glargine there was an increase in basal and a decrease in mealtime insulin requirements (P Ͻ 0.05). Frequency of mild hypoglycemia (self-assisted episodes, blood glucose Յ4.0 mmol/l) was lower with glargine (dinnertime 8.1 Ϯ 0.8 mmol/l, bedtime 7.7 Ϯ 0.9 mmol/l) than with NPH (12.2 Ϯ 1.3 mmol/l) (episodes/patient-month, P Ͻ 0.04). In-hospital profiles confirmed outpatient blood glucose data and indicated more steady plasma insulin concentrations at night and before meals with glargine versus NPH (P Ͻ 0.05). There were no differences between glargine given at dinnertime and at bedtime.CONCLUSIONS -Regimens of basal insulin with either NPH four times/day or glargine once/day in type 1 diabetic patients both result in good glycemic control. However, the simpler glargine regimen decreases the HbA 1c level and frequency of hypoglycemia versus NPH. In contrast to NPH, which should be given at bedtime, insulin glargine can be administered at dinnertime without deteriorating blood glucose control. Diabetes Care 26:1490 -1496, 2003W hen rapid-acting insulin analogs are used in type 1 diabetic patients as mealtime insulin in place of human regular insulin, intensification of replacement of basal insulin is needed to improve long-term blood glucose control (1,2). This is best achieved with either continuous subcutaneous insulin infusion (3-5) or multiple daily administrations of NPH in addition to the rapid-acting insulin analog (6 -12).The long-acting insulin analog glargine exhibits an action profile flatter and longer than that of NPH insulin (1,13,14). Therefore, it is expected that use of glargine translates into bene...
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